1. Field of the Invention
The present invention relates to improvements in the procedure for suturing tissue during endoscopic/laparoscopic surgery, and to a method of suturing which utilizes a modified laparoscopic grasper and a guide. More particularly, the improved method relates to suturing of ligaments using a needle-point suture passer to retract and reinforce the ligaments, applications including uterine suspension and positioning.
2. Description of the Related Art
An endoscopic/laparoscopy procedure involves making small surgical incisions in a patient's body for the insertion of trocar tubes thereby creating access ports into the patient's body. Thereafter, various types of endoscopic/laparoscopic instruments are passed through these access ports and the appropriate surgical procedures are carried out.
After the surgical procedure is performed, the trocar tubes are removed and the incisions sutured closed by using both a needle and grasper for penetrating the tissue and handling the suture. This procedure for closure is frequently a time-consuming procedure requiring the identification of the fascia and closure of each fascial site with suture from an external point.
The necessity for closing these port sites in laparoscopic surgery is critical since suturing the incisions improperly can lead to bowel herniation through the port sites as well as the possibility of mental trapping if the fascial sites are not properly closed. Incisional hernias have occurred in both laparoscopic-assisted vaginal hysterectomies and laparoscopic cholecystectomies as well as other advanced laparoscopic procedures.
Thus there is a need for an endoscopic/laparoscopic instrument and method which will significantly reduce the operating time and is better able to give the surgeon direct visualization of the fascial and peritoneal closing. Additionally, there is a need for a surgical instrument which allows the surgeon to control bleeding sites by rapidly putting sutures around blood vessels of the abdominal wall.
Furthermore, there is a need to accurately and consistently guide and orient an endoscopic/laparoscopic instrument into proper position to accurately and easily provide for placement and retrieval of suture materials within an open wound to be closed.
The subject invention herein solves all of these problems in a new and unique manner which has not been part of the art previously. General types of surgical forceps and laparoscopic graspers are known in the art, and some related patents directed to surgical instruments or guides are described below:
U.S. Pat. No. 5,192,298 issued to W. Smith et al. on Mar. 9, 1993
This patent is directed to a disposable laparoscopic surgical instrument. The laparoscopic surgical instrument comprises a tube surrounded by a peripheral insulating shrink-wrap layer, a clevis means, effectors pivotally engaged to the clevis at a pivot pin, and activating means. The effectors are provided with blades or graspers which taper to a point and are rotatably mounted on the pivot pin.
U.S. Pat. No. 5,201,743 issued to T. Habeir et al. on Apr. 13, 1993
This patent is directed to an axially extendable endoscopic surgical instrument. The endoscopic surgical instrument includes an elongate body, a tip carrier tube, a tip assembly removably mounted to the distal end of the carrier tube and having a pair of movable jaws, a driver assembly which causes jaws to move between open and closed positions, and a jaw-rotating assembly which causes the tip assembly and jaws therewith to rotate about an axis. The jaws taper substantially at their distal ends, and the interior surface of the jaws are serrated.
U.S. Pat. No. 4,950,273 issued to J. M. Briggs on Aug. 21, 1990
This patent is directed to a cable-action instrument. The instrument comprises a controller, a reaction end, and an angle adjustment section which connects the controller to the reaction end, and a flexible control cable assembly extending between the controller and the reaction end. The reaction end consists of a scissors tip having a stationary blade and a cable-activated blade, both of which have pointed distal ends. A forceps instrument tip having a stationary plant arm and a cable-activated arm may be substituted for the scissors tip.
U.S. Pat. No. 4,938,214 issued to P. Specht et al. on Jul. 3, 1990
This patent is directed to a hand-held surgical tool. The surgical tool includes an operating end having first and second blade tips which are movable between open and closed positions. When the blade tips are closed, the surgical tool has a needle-sharp point having a diameter of only about 50 microns to 2 mm.
U.S. Pat. No. 3,577,991 issued to G. R. Wilkinson on May 11, 1971
This patent is directed to a tissue-sewing instrument, the forceps are pivoted together with the outer jaws and a spring set between the members. The thread slides to the end of the forceps, and the free end of the thread is pulled through the loops to make a knot.
U.S. Pat. No. 5,196,023 issued to W. Martin on Mar. 23, 1993
This patent is directed to a surgical needle holder and cutter wherein the cutter forming the upper part of the blade has a concave shape. When the forceps jaw is opened, an approximately elliptical opening is formed between the ridge, or cutter, and the depression into which a thread may be brought from the direction of the opening of the forceps jaw and then can be cut off by closing the jaw.
U.S. Pat. No. 5,222,508 issued to O. Contarini on Jun. 29, 1993
This patent is directed to methods for closing punctures and small wounds of the human body, allowing such punctures to be sutured and closed with an internal seal. Before the trocar is removed, a suture insertion means, a needle preferably of stainless steel, having an eyelet or a slot or barb to retain the suture material, is pushed completely through the skin and subcutaneous layer. A retrieval means is inserted adjacent the puncture so its barbed portion grasps or snares the free end of the suture material. The insertion needle, retrieval needle, and trocar are withdrawn and the suture drawn tight.
U.S. Pat. No. 5,053,043 issued to J. Gottesman et al. on Oct. 1, 1991
This patent is directed to a suture guide with interchangeable tips for placing sutures in the severed end of a body duct. Various tips having one or more apertures and channels for placing sutures are provided to screw into an elongate member. The elongate member has a handle at the opposite end. This guide is particularly useful for the placement of sutures into the urethral stump.
U.S. Pat. No. 5,201,744 issued to M. W. Jones on Apr. 13, 1993
This patent is directed to a method and device for suturing using a rod with a needle holder. This device, a knot-tier instrument, has a rod with an end having notches for guiding suturing threads, and a slot for holding a needle. The end may be magnetized to aid in magnetically holding the needle in the slot. A hollow cannula, or access tube, can be inserted through the skin, and the knot tier inserted into the cannula for suturing the wound closed.
U.S. Pat. No. 5,176,691 issued to J. Pierce on Jan. 5, 1993
The patent is directed to a plurality of embodiments of knot pushers formed from elongated rods. The pusher with an elongated rod has various configurations to guide suture ends and push the knot. The end of the rod has a face shaped to push the knot, and near the edges of the rod are eyelets or grooves or the like to guide the sutures as the knot is being pushed. The purpose of the device is to advance the knot of a suture through an endoscope portal or a cannula or the like.
U.S. Pat. No. 4,621,640 issued to J. S. Mulhollan on Nov. 11, 1986
This patent is directed to a mechanical needle carrier which can grasp and carry a surgical needle through a cannula, position the needle, and set a stitch at a remote location, then release the needle for withdrawal from the cannula. The mechanical needle carrier is inserted through the cannula, and a pivotal needle-carrying head is positioned by adjusting knurled knobs so as to position the needle as required. Once the needle is set, it can be released and then retrieved by forceps or the like. This mechanical needle carrier provides the structure for suturing in a restricted field with the manipulation remote from the location of the needle.
Intra-abdominal suturing is a time-consuming process for surgeons in part because a lot of manipulation and "fiddling" is associated with the needle attached to the suture material. For instance, the needle and suture material must be aligned so they can pass through a trocar sleeve. As curved needles will only fit through large trocar sleeves, larger wounds must be made for the trocars in order to pass the curved needles into the body cavity. Once inside the abdominal cavity, the needle has to be grasped, regrasped, aligned, and realigned in the needle driver. After each stitch, the needle has be to be grasped and realigned in the needle driver.
With the present invention, the needle driver and the needle are one and the same. Therefore, the disadvantages presented by having an independent needle are avoided. Suturing can start immediately without the frustration of continually realigning the needle when it is regrasped. The surgeon simply passes the suture through the tissue then, by either using the same instrument or a standard grasper, picks up the suture for tying or passing through the tissue to create another stitch for wound closure. The present invention allows introduction of suture directly through tissue or through small trocar sites, as the diameter of the shaft and its tip for the probe is generally much smaller than the average trocar. Additionally, the technique for using the present invention is easily learned; and the several embodiments set forth herein generally reduce the time and frustration associated with intra-abdominal suturing. These advantages are enhanced by use of the guide disclosed herein.
Laparoscopic surgical procedures have been used in attempts to correct misalignment of a woman's uterus. This misalignment is most often seen as a retroverted, backward-bending uterus, but can also be an anterior misalignment where the uterus is situated more towards the front than is desired. Symptoms reported as a result include chronic pelvic pain, pain on intercourse, debilitating pain during menstrual cycles, urinary problems, bowel problems, infertility and back pain.
It has been found that repositioning the uterus to a more midline position in the pelvis relieves symptoms in a great percentage of these patients. To that end a number of surgical procedures have been attempted to perform the correction.
The corrections revolve around surgeon's observations that ligaments, or tough bands of tissue which normally function to hold the uterus in a neutral position, are or have become stretched, thinned or loosened from their attachment points. Procedures designed to shorten and/or reattach these ineffective ligaments include the following:
Gilliams Procedure
The Gilliams procedure was designed to remove a section of the ligament and suture the ends back together. The resulting shortened ligaments provide more tension to hold the uterus in a neutral position. Among the drawbacks to Gilliams procedure is that it does nothing to improve the strength of thinned ligaments and they may again stretch so that the correction would be short lived. Additionally, Gilliams procedure can change the geometry of the lower pelvis when ligaments are reattached to the anterior abdominal wall, creating a pouch that may entrap the bowel which is a serious complication.
Webster-Baldy Procedure
The Webster-Baldy procedure creates a new attachment point for one ligament by passing it through another and suturing it to the wall of the lower uterine corpus.
This stretching of the ligament to a second attachment point on the uterus creates more tension with which to hold the uterus. This correction does not take advantage of the thickest part of the ligament which is the part already attached to the uterus. Changing the attachment point does nothing to improve the strength of these thinned ligaments and they may be prone to restretch.
Mann-Stenger Uterine Suspension, Candy's Modified Gilliam Uterine Suspension, Pereyra Needle Uterine Suspension, Doleris's Procedure
The above procedures rely on passing suture one or more times around or through the ligament and then directly attaching the loose ends of suture to the abdominal wall for the purpose of putting more tension on the ligaments that support the uterus. The procedures do not reinforce thinned ligaments which may stretch and loosen from the fixation. They also create a cavity-like space in the anterior cul-de-sac where bowel intussusception will be most likely to occur. This may lead to a slipping of a length of intestine into an adjacent portion, which may produce an obstruction.
In contrast, the present invention uses a needle-point suture passer to carry and withdraw suture longitudinally into the ligament from a point at or near the ligament's original fixation point. Using this method, the thinned part of the ligament is reinforced with permanent suture, thus significantly reducing the risk of additional stretching. By tunneling into the ligament from the area near the natural attachment point, the natural geometry of the lower pelvis is preserved which reduces the risk of complications.